Joint Development Committee Clause Samples
The Joint Development Committee clause establishes a formal group composed of representatives from the parties involved in a joint development project. This committee is typically responsible for overseeing the progress of the project, making key decisions, resolving disputes, and coordinating activities between the parties. For example, the committee may set project milestones, approve budgets, or address technical challenges as they arise. Its core practical function is to provide a structured mechanism for collaborative decision-making and governance, ensuring that both parties have input and oversight throughout the development process.
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Joint Development Committee. […***…] after the Effective Date, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JDC are:
(a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…];
(b) to review and approve the conduct by Mirati of any Development activities with respect to any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…];
(c) to review and approve the Development Plan, with the understanding that the Initial Development Plan has been approved by the Parties, and any material amendments or revisions thereto;
(d) to review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 15 *** Confidential Treatment Requested
(e) to review all material […***…];
(f) to provide a forum for discussion of and coordinate interactions with Regulatory Authorities […***…];
(g) to review any material Regulatory Filings with respect to the Licensed Product to be submitted to any Regulatory Authority […***…];
(h) to review and discuss […***…];
(i) to discuss and provide a forum for the exchange of pharmacovigilance and safety matters;
(j) to provide a forum for discussion of and coordinate decisions related to […***…]; and
(k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and
(l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the Develo...
Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party.
(b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans.
(c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria.
(d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [*...
Joint Development Committee. The Parties will establish a joint development committee (“JDC” or “Joint Development Committee”) within 30 days after the Effective Date to oversee, coordinate, and discuss development of the Instrument and Cartridges as set forth in the applicable SOWs attached to this Agreement, and the Parties’ corresponding activities under this Agreement.
Joint Development Committee. Promptly after the Effective Date, the JSC shall establish a joint development committee (“JDC”). The JDC shall have primary responsibility for the matters set forth in Section 3.1.2(a) - 3.1.2(f) and 3.1.2(h) - 3.1.2(j), together with such other matters as are delegated to the JDC by the JSC.
Joint Development Committee. The Parties will form a joint development committee (the “JDC”) to serve as a forum for information exchange and discussion with respect to development and regulatory activities relating to Compounds and Products in the Field in the Territory.
Joint Development Committee. The Parties will establish a single Joint Development Committee (the “JDC”) to oversee and coordinate the activities under all Research Programs in accordance with the remainder of this Article 3. The JDC shall be comprised of two (2) employees from Spyre or Aeglea and two (2) employees from Paragon, with each Party designating one (1) such employee as its JDC co-chairperson. Subject to the foregoing, each Party shall appoint its respective Representatives to the JDC from time to time, and may change its Representatives, in its sole discretion, effective upon notice to the other Parties designating such change. Representatives from each Party shall have appropriate technical credentials, experience and knowledge pertaining to and ongoing familiarity with the activities to be performed under the Research Programs.
Joint Development Committee. Within thirty (30) days from the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee”) to coordinate and oversee the development of the Assay in the Territory.
Joint Development Committee. 4.1 Within thirty (30) days after the effective date of this Agreement, each Party shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement.
4.2 The Parties shall establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”). The Joint Development Committee shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on any issue that comes before the JDC, then the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have day-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreement.
4.3 The JDC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every month. Meetings of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the Parties. Each Party shall be responsible for all of its own expenses of participating in the JDC. No action t...
Joint Development Committee. Within thirty (30) days of the Effective Date of this Agreement, GenuPro and Licensee shall assemble a JDC. Initially, the JDC will be composed of at least two, but no more than four, representatives each from GenuPro or its Affiliates and Licensee. The initial members of the JDC will be those representatives the names of whom will be provided to the other Party within ten days after the Effective Date. Each Party will promptly notify the other Party in writing of any change in its appointed representatives. The chairperson of the JDC will be one of Licensee’s representatives.
Joint Development Committee. Within thirty (30) days of the Effective Date, Wyeth and Trubion shall establish a CD20 Product Joint Development Committee (the "JDC"), comprised of appropriate representatives of both Parties, to review and provide input to Wyeth regarding CD20 Product Development in the Territory, including the strategic direction of the overall CD20 Product Development program. Wyeth shall consider in good faith any of Trubion JDC members' comments and recommendations regarding CD20 Product Development, but Wyeth shall have final decision-making authority with respect to how the Parties proceed with CD20 Product Development, subject to Wyeth's obligations under Section 4.1 in connection therewith. If Trubion disagrees with an action or decision by the JDC, Trubion may express its concerns through good faith discussions between the Executive Officers of Trubion and Wyeth, with Wyeth Research's President having the final decision-making authority with respect to such matter. For the avoidance of doubt, the JDC may not impose different or greater CD20 Product Development obligations on Trubion than those specified in Section 4.6.